US FDA Clears First 3D-Printed Prescription Drug

The Food and Drug Administration has approved the first prescription drug made through 3D printing: a dissolvable tablet that treats seizures.

Aprecia Pharmaceuticals said Monday the FDA approved its drug Spritam for adults and children who suffer from certain types of seizures caused by epilepsy. The tablet is manufactured through a layered process via 3D printing and dissolves when taken with liquid.

The Ohio-based company says its printing system can package potent drug doses of up to 1,000 milligrams into individual tablets. It expects to launch Spritam in the first quarter of 2016.

The FDA has previously approved medical devices – including prosthetics – made with 3D printing. An agency spokeswoman confirmed the new drug is the first prescription tablet approved that uses the process.

Aprecia said in a statement it plans to develop other medications using its 3D platform in coming years, including more neurological drugs. The company is privately owned.

Doctors are increasingly turning to 3D printing to create customized implants for patients with rare conditions and injuries, including children who cannot be treated with adult-size devices. The FDA held a workshop last year for medical manufacturers interested in the technology.